1. The “Never Event” in Patient Safety David Gourley, MHA, RRT, CPHRM, FAARC Director of Quality and Outcomes Mgmt. Chilton Medical Center Pompton Plains, New Jersey

2. Conflict of Interest I have no real or perceived conflict of interest that relates to this presentation. Any use of brand names is not in any way meant to be an endorsement of a specific product, but to merely illustrate a point of emphasis.

3. Objectives Learning objectives for this presentation: Describe the origin of “never events” Explain the human and financial impact of never events Identify the never events of concern to the RT Describe the relationship between never events and hospital acquired conditions

4. “Never Events” Overview of “Never Events” Criteria for Inclusion as Never Events Impact of Never Events Categories of Never Events Accountability of Healthcare Organizations CMS Hospital Acquired Conditions Concept of “Never” Case Studies

5. “Never Events” What is your knowledge of “Never Events” ▫Thoroughly knowledgeable ▫Working knowledge ▫Some familiarity ▫No knowledge

6. “Never Events” Spearheaded by IOM report “To Err is Human” National Quality Forum established in 2002 Originally 27 serious reportable events, expanded to 29 Considered “largely preventable” Have been incorporated by 26 states and DC into patient safety reporting systems

7. “Never Events” Established to facilitate uniform and comparable public reporting Enable systematic learning Drive national improvements in patient safety

8. “Never Events” According to the National Quality Forum: Never events are “of concern to both the public and healthcare professionals and providers; clearly identifiable and measurable and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the healthcare organization”

9. Criteria for Inclusion as “Never Event” Unambiguous Largely, if not entirely preventable Serious Any of the following: ▫Adverse ▫Indicative of a problem in healthcare safety systems ▫Important for public credibility or accountability

10. Criteria for Inclusion as “Never Event” Of concern to both the public and healthcare professionals and providers Clearly identifiable and measurable Of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the healthcare facility

11. Impact of Never Events 2 million events annually 90,000 deaths annually $5.7 billion in added healthcare costs $29 billion in associated costs (additional health care expenses, lost work & income, disability)

12. Categories of “Never Events” Surgical or Invasive Procedure Events Product or Device Events Patient Protection Events Care Management Events Environmental Events Radiologic Events Potential Criminal Events

13. Surgical or Invasive Procedure Events Surgery/other invasive procedure performed on the wrong site Surgery/other invasive procedure performed on the wrong patient Wrong surgical/other invasive procedure performed on a patient Unintended retention of a foreign object Intraoperative or immediate post- op/procedure death in ASA Class 1 patient

14. Product or Device Events Patient death/serious injury associated with contaminated drugs, devices, or biologics Patient death/serious injury associated with use or function of device Patient death/serious injury associated with intravascular air embolism

15. Patient Protection Events Discharge or release of patient who is unable to make decisions, to other than authorized person Patient death/serious injury associated with patient elopement Patient suicide, attempted suicide, or self harm that results in serious injury

16. Care Management Events Patient death/serious injury associated with medication error (wrong drug, dose, patient, time, rate, preparation, or route) Patient death/serious injury associated with administration of blood products Maternal death/serious injury associated with labor or delivery in low-risk pregnancy Death/serious injury of neonate associated with labor or delivery in low-risk pregnancy

17. Care Management Events (cont.) Patient death/serious injury associated with a fall Stage 3 or 4, and unstageable pressure ulcers acquired after admission Artificial insemination with wrong donor sperm or egg Patient death/serious injury from loss of irreplaceable biological specimen Patient death/serious injury from failure to f/u or communicate lab, pathology, or radiology results

18. Environmental Events Patient or staff death/serious injury associated with electric shock in the course of pt. care Medical gas mix-up (no gas, wrong gas, contaminated by toxic substances) Patient or staff death/serious injury associated with burn from any source in the course of pt. care Patient death/serious injury associated with physical restraints or bedrails

19. Radiologic Events Death/serious injury of a patient or staff associated with introduction of a metallic object into the MRI area July 31, 2001 Boy, 6, Dies Of Skull Injury During M.R.I.

20. Potential Criminal Events Any care ordered by/provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider Abduction of a patient of any age Sexual abuse/assault on a patient or staff member Death/serious injury of patient or staff member from physical assault

21. Accountability of Healthcare Organizations Diligent effort to discover vulnerabilities that could lead to adverse events Focused review and analysis of events ▫Determine causal and contributing factors Applying what is learned to continuous quality improvement Public reporting of adverse events

22. State Reporting of Adverse Events 26 states and District of Columbia have enacted reporting systems for adverse events State defined lists: FL, GA, KS, MD, NE, NV, OH, PA, RI, SC, SD, TN, UT Modified NQF lists: CA, CO, CT, DC, MA, NJ, NY, OR, WA NQF SREs: IL, IN, MN, NH, VT

23. 2011 Update Ensure continued currency and appropriateness Ensure events are appropriate for continued public reporting Provide guidance to new reporters Clarifying events to be reported by other settings: ▫Office-based practices ▫Ambulatory surgical centers ▫Skilled nursing facilities

24. CMS Hospital Acquired Conditions CMS identified 11 conditions (HAC’s) Beginning October 1, 2008, no longer pays hospitals for increased costs resulting from HAC’s HAC’s overlaps “Never Events” Intent to improve quality of care Implements “pay for performance” Adopted by some third party payors

25. CMS Hospital Acquired Conditions HOSPITAL ACQUIRED CONDITIONS (HAC’s) Foreign object retained after surgery Blood incompatibility Air embolism Stage 3 or 4 pressure ulcers Falls and trauma (fracture, dislocation, intracranial injury, crashing injury, burn, electric shock Catheter-associated urinary tract infections Vascular catheter-associated infections Manifestations of poor glycemic control Surgical site infections following CABG Surgical site infections following certain orthopedic procedures (spine, neck, shoulder) Surgical site infections following bariatric surgery DVT or PE following certain orthopedic procedures (total hip or knee)

26. CMS Hospital Acquired Conditions CONDITION# REPORTED ANNUAL EVENTS Pressure Ulcers257,412 Falls/Trauma193,566 Central Line Associated Bloodstream Infections (CLABSI) 16,060 Catheter Associated Urinary Tract Infections (CAUTI)12,185 Foreign Object Retained after Surgery750 Surgical Site Infections747 Air Embolism57 Blood Incompatibility24

27. Concept of “Never” Is the term “never events” a misnomer Are “never events” truly preventable? Is “never” an expectation or a goal? Do issues such as comorbidities, age, gender, hospital variables affect outcomes Philosophy of “Getting to Zero” Adopting principles of High Reliability Organizations (HRO)

28. Never Events Have you ever been involved in one???? Yes No

29. Case study # 1 78 year old female End-stage COPD Chronic ventilatory failure Refusing intubation Using NIPPV 18 – 20 hours per day On day 7, pressure ulcer noticed on bridge of nose by Respiratory Therapist Continues on NIPPV Pressure ulcer progresses to stage 3

30. “Never Event” Assessment Have you ever been involved in a similar event? YES NO Was it handled as a never event at your facility? YES NO Were changes implemented to prevent similar events in the future? YES NO Have they been successful in preventing future events? YES NO

31. Case Study # 2 62 year old male Brought to ED with SOB and chest pain History of CHF EMS crew had patient on NRB mask @ 15 LPM Patient experiences cardiac arrest and is not successfully resuscitated RT identifies that NRB mask was connected to compressed air, not oxygen

32. “Never Event” Assessment Have you ever been involved in a similar event? YES NO Was it handled as a never event at your facility? YES NO Were changes implemented to prevent similar events in the future? YES NO Have they been successful in preventing future events? YES NO

33. Case study # 3 50 year old healthy female Hysterectomy performed on Tuesday afternoon Wednesday afternoon, patient experiencing moderate abdominal pain, fever, and vomiting Patient deteriorates into ventilatory failure Brought back to OR, perforated bowel identified Patient experiences cardiac arrest and is not successfully resuscitated

34. “Never Event” Assessment Have you ever been involved in a similar event? YES NO Was it handled as a never event at your facility? YES NO Were changes implemented to prevent similar events in the future? YES NO Have they been successful in preventing future events? YES NO

35. Case study # 4 28 year old female Just returned home from airplane flight from Tokyo Brought to ED with chest pain and SOB ABG performed: pH – 7.45, PCO2 – 29.8, PO2 – 43.8 RT distracted by Code Blue, ABG never reported Patient experiences cardiac arrest, is resuscitated and dx. of pulmonary emboli

36. “Never Event” Assessment Have you ever been involved in a similar event? YES NO Was it handled as a never event at your facility? YES NO Were changes implemented to prevent similar events in the future? YES NO Have they been successful in preventing future events? YES NO

37. Case study # 5 66 year old male Admitted with shortness of breath Dx. with Legionella pneumophila On third day, condition deteriorates, Rapid Response Team called RT prepares to intubate, laryngoscope not functioning 8 minute delay in intubation Patient experiences cardiac arrest and expires

38. “Never Event” Assessment Have you ever been involved in a similar event? YES NO Was it handled as a never event at your facility? YES NO Were changes implemented to prevent similar events in the future? YES NO Have they been successful in preventing future events? YES NO

39. “Never Events” CMS Never Events, rL Solutions, October 2008 The Leapfrog Group, Never Events Fact Sheet, March 2008 Serious Reportable Events in Healthcare – 2011 Update, National Quality Forum Serious Reportable Events, Transparency, accountability, critical in reducing medical errors and harm, National Quality Forum

40. “Never Events”